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0x4F3A... SCANNING

DOC_ID_992... VERIFIED

vector_db... SYNC

0x11B... CHECK

semantic_layer... OK

0x99A... PARSING

GDPR_art_5... PASS

0xCC2... LOAD

integrity_hash... MATCH

0x4F3A... SCANNING

DOC_ID_992... VERIFIED

vector_db... SYNC

0x11B... CHECK

semantic_layer... OK

EN / RO

THE REGULATORY ORACLE

Sovereign AI Governance for High-Stakes Industries. Automate compliance, eliminate hallucinations, and secure your competitive edge in the age of the EU AI Act and FDA 21 CFR.

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Precision Retrieval for Pharma

What is RAG and why does it mean "Mega Safety"?

Standard AI guesses answers based on patterns, which inevitably leads to hallucinations. Retrieval-Augmented Generation forces our Oracle to physically extract the exact regulatory article from our encrypted database before analyzing your document. Zero guessing. 100% mathematical compliance.

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Regulatory Chunking

// PDFProcessor.extract_text()

Detecting legal boundaries...

regex: (Article|Art\.|Section)\s+\d+

{"law_id": "eu_ai_act", "article_no": "12"}

Status: Indexed Vectors: 1000-dim
database ChromaDB
Vector Store

Deterministic Retrieval

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// Similarity_Search(top_k=5)

Querying Augmented Context...

[MATCH] similarity_score: 0.94

chunk: "eu_gdpr (Article 9)"

Hash: 0x82...3f1 Context: Augmented
memory Azure Embeddings
database ChromaDB Core
verified ALCOA+ Validation
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Architecture Designed for Compliance,
Not Just Conversation.

Unlike commercial generative models, Aiudit operates on a sovereign architecture. We decouple language processing from data storage, guaranteeing your sensitive intel remains proprietary while our Oracle verifies compliance with mathematical precision.

SOC2 & ISO Aligned Architecture Horizontal Scalability Multi-Jurisdictional Logic

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Weaver Engine Active
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Client QMS/DMS
Aiudit
Weaver Hub
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Airtight Enclave
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The Airtight Fortress

Zero Data Egress. Data never leaves the enclave and is never used to train public LLMs. AES-256 & TLS 1.3 encryption.

Zero-Knowledge
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Deterministic AI

No generative guessing. Mathematical validation against legal text with Deep Link Audit Trails for every flagged gap.

Hallucination-Free
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Hybrid Deployment

Cloud Velocity for scaling, or On-Premise Docker/K8s for absolute sovereignty. API-First design integrates anywhere.

Cloud & On-Prem

Triple-Agent
Orchestration

01. The Auditor

Scans and maps textual inconsistencies.

02. The Guardian

Evaluates critical vs. minor risk severities.

03. The Weaver

Synthesizes the certified audit report.

gavel Regulatory Codex

Pre-indexed global and national legal frameworks.

🇷🇴 Romania National

  • Legea 95/2006 (Healthcare Codex)
  • Ordin MS 1162/2010 (GMP RO)
  • Ordin MS 1502/2016 (GDP Logistics)
  • Ordin MS 1101/2016 (Sanitation)

🇪🇺 European Union Core

  • EU AI Act (2024 Framework)
  • MDR (EU 2017/745)
  • IVDR (EU 2017/746)
  • GDPR Art. 22 Compliance
  • EU GMP Annex 11

🌎 Global Pharma & US

  • FDA 21 CFR Part 11
  • GAMP 5 Validation
  • ICH E6 (R2/R3) Clinical
  • ICH Q9 Risk Mgmt
  • HIPAA Data Privacy
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Custom SOP Injection & Live Review You don't just receive a static report. For SaaS & Airtight users, Weaver opens a live review session where you can correct documents assisted by AI and experts, closing compliance gaps on the spot.
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Architecture Designed for Compliance

Deterministic logic meets biotech-grade security. A sovereign infrastructure for the clinical era.

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Airtight Fortress

On-premise or private cloud deployment. Your data never leaves your regulatory perimeter.

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Deterministic AI

Zero hallucination protocol. Every audit finding is linked to a specific law (Annex 11, GAMP 5).

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Hybrid Deployment

Seamlessly bridge legacy document repositories with modern AI-driven compliance workflows.

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SHA-256 Integrity Seal

Every audit report is mathematically signed with a 256-bit cryptographic hash. Ensures 100% data immutability and ALCOA+ compliance.

Active Protection
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Enterprise-Ready DPA

Standard EU Model Clauses & DPA ready for immediate signature. Compliant with international data transfer protocols.

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Transparent AI Ethics

Deterministic, non-generative auditing ensures zero black-box neural bias. Every decision is traceable back to its legal source.

verified 24/7 Expert Access

Clinical Consultation Hub

Connect with our board-certified auditors for specialized pharmaceutical compliance, risk mitigation, and regulatory strategy.

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ISO 27001 Infrastructure

Built on SOC2 & ISO-compliant cloud architecture.

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Regulatory Alignment

Protocols aligned with EU AI Act safety guidelines and GxP standards.

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Send Secure Inquiry

Response time: Usually under 2 clinical hours.

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